Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K212813 |
Device Name |
Zenition 70 |
Applicant |
Philips Medical Systems Nederland BV |
Veenpluis 4-6 |
Best,
NL
5684PC
|
|
Applicant Contact |
Swapnil Sharadkumar Jain |
Correspondent |
Philips Medical Systems Nederland BV |
Veenpluis 4-6 |
Best,
NL
5684PC
|
|
Correspondent Contact |
Swapnil Sharadkumar Jain |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/03/2021 |
Decision Date | 10/01/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|